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Papillomavirus Infections

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Vaccines

Human Papillomavirus (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Quadrivalent Human Papillomavirus (HPV, Types 6, 11, 16, 18) Recombinant Vaccine (Gardasil®)

aluminum-contained, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Comparator: Placebo

Medical Monitor

This is a China registration study. A randomized, double-blind, placebo-controlled immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1 ratio to receive either vaccine or aluminum-containing placebo. Each participant received one injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a 0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health concerns and Serious Adverse Experiences throughout the study. The primary objective is to evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose regimen of Gardasil® compared with placebo.

An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

An Immunogenicity and Safety Study of Quadrivalent HPV (Types 6, 11, 16, 18) Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array.

The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) \<7, \<8, \<11, \<10 respectively)

Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.

Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7

All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.

Merck Sharp & Dohme LLC

Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Vaccine (Gardasil®) Group

Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6

Placebo Group

Total

Age, Continuous

9-15 Years of Age

16-26 Years of Age

27-34 Years of Age

35-45 Years of Age

Age, Customized

Sex: Female, Male

Body Temperature

Pulse

Vice President, Late Stage Development Group Leader

An Analysis of Covariance (ANCOVA) model was used for each HPV type, based on the pooled data from all age groups and genders. The natural-log-transformed titer was the response variable, and vaccination group, gender and age group were covariates. The null hypothesis was that the GMT ratio (Gardasil/Placebo) was equal to 1.

anti-HPV 6

anti-HPV 11

anti-HPV 16

anti-HPV 18

Vaccine (Gardasil®) Group (Day 1)

Placebo Group (Day 1)

Vaccine (Gardasil®) Group (Month 7)

Placebo Group (Month 7)

Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.

Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)

The null hypothesis was that the seroconversion rate in the Gardasil® Group was less than 90% for each HPV type.

Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7

Safety population, defined as all participants who were vaccinated at least one dose and had safety follow-up data

Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)	NCT00496626	Papillomavirus ...	Quadrivalent Hu... Comparator: Pla...	9 Years - 45 Years	Merck Sharp & Dohme LLC
An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)	NCT00496626	Papillomavirus ...	Quadrivalent Hu... Comparator: Pla...	9 Years - 45 Years	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for quadrivalent human papillomavirus (hpv, types 6, 11, 16, 18) recombinant vaccine (gardasil®)